Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia (MDCwProbe)
Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
研究概览
详细说明
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Leonid Fradkin, PhD
- 电话号码：718-240-8225
- 邮箱：lfradkin@bhmcny.org
研究联系人备份
- 姓名：Thelma Carrillo, MPH
- 电话号码：718-240-5978
- 邮箱：tcarrill@bhmcny.org
学习地点
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New York
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Brooklyn、New York、美国、11212
- 招聘中
- Brookdale University Hospital and Medical Center
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接触：
- Leonid Fradkin, PhD
- 电话号码：718-240-8225
- 邮箱：lfradkin@bhmcny.org
-
接触：
- Thelma Carrillo, MPH
- 电话号码：718-240-5978
- 邮箱：tcarrill@bhmcny.org
-
首席研究员：
- Michele Follen, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women who are at least 18 years old
- Are not pregnant (negative urine test) or breastfeeding
- Referred for colposcopy or LEEP treatment
- Can provide written informed consent
Exclusion Criteria:
- Women who do not meet the inclusion criteria
- Women who have had a hysterectomy
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Routine colposcopy and MDC with probe
The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure.
A control biopsy will also be obtained from patients who agree to provide it.
The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.
|
Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Detection of precancerous cervical lesions or cervical cancer
大体时间：At point of care for colposcopy or treatment with LEEP (5 minutes).
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Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied. |
At point of care for colposcopy or treatment with LEEP (5 minutes).
|
合作者和调查者
调查人员
- 首席研究员：Michele Follen, MD, PhD、Brookdale University Hospital and Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.